Effects of a probiotic fermented milk on functional constipation: A randomized, double-blind, placebo-controlled study

• Published in: Journal of gastroenterology and hepatology 2013-07, Vol.28 (7), p.1141-1147
• Main Authors: Mazlyn, Mena Mustapha, Nagarajah, Lee Hun-Leong, Fatimah, Arshad, Norimah, A Karim, Goh, Khean-Lee
• Format: Article
• Language: English
• Subjects: Adult; constipation; Constipation - ethnology; Constipation - therapy; Cultured Milk Products - microbiology; Defecation - physiology; Double-Blind Method; Female; Humans; Lactobacillus casei; Lactobacillus casei - physiology; Male; Placebos; probiotics; Probiotics - therapeutic use; Severity of Illness Index; Time Factors; Treatment Outcome
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/jgh.12168

Background and Aim Evidence suggests that probiotics reduce certain constipation‐related symptoms. Lactobacillus casei strain Shirota has never been tested as treatment for functional constipation in otherwise‐healthy subjects. To evaluate the efficacy of this probiotic among adults with functional constipation was aimed. Methods Subjects with functional constipation (Rome II‐defined) were randomized to intake L. casei strain Shirota fermented milk or placebo once daily for 4 weeks under double‐blind condition. Primary outcomes were constipation severity and stool frequency; secondary outcomes were stool consistency and quantity. Results  In intent‐to‐treat population, compared with baseline, constipation severity and stool frequency improved in both probiotic (n = 47) and control groups (n = 43), but improvements were comparable in both groups at week 4 (α = 5% level). In probiotic group, stool consistency and quantity at week 4 improved significantly versus baseline but not versus control. Considering that the study agent is non‐pharmaceutical and the purpose of supplementation is for long‐term effect, re‐evaluation at α = 10% was conducted, which showed significant improvement in constipation severity at week 4 (P = 0.058). Magnitude of the probiotic effect on stool consistency was small but grew over time, d = 0.19, 95% confidence interval 0.00–0.35 (Week 4), d = 0.29, 95% confidence interval 0.11–0.52 (postintervention). Post‐hoc exploratory analysis suggests incomplete evacuation may decrease with probiotic intake. Conclusions Four‐week administration of L. casei strain Shirota did not alleviate constipation severity or stool frequency, consistency, and quantity when compared with control. With re‐evaluation at α = 10% level, improvement in constipation severity was significant at week 4. To obtain conclusive results, further studies with longer intervention are warranted.